Senior Manager, Aggregate Reporting Management

About the role

The Senior Manager, Aggregate Reporting Management plays a crucial role in the Global Patient Safety (GPS) Operations, managing safety reporting activities across all phases of the product lifecycle. This includes preparing, distributing, and submitting periodic and ad-hoc safety reports to health authorities, collaborators, and contract research organizations worldwide.

Responsibilities

• Deliverables: Leads Aggregate Report planning, production, and distribution activities across GPS and other functions across US, EU, Japan, and other ICH regions, as well as non-ICH regions.
• Expertise and Guidance: Provides expertise and guidance to authors and contributors of aggregate reports.
• Compliance Metrics: Maintains compliance metrics and contributes to implementation of Quality Events and Corrective Action and Preventive Action (CAPA) for non-compliance.
• Timely and High-Quality Outputs: Implements effective structure, procedures, and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality.
• Data Requirements: Develops and oversees functional specifications of data requirements for aggregate deliverables from the safety and clinical databases.
• Collaboration: Collaborates with Global Patient Safety (GPS) and with other functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports.
• Audits and Inspections: Acts as a subject matter expert during audits and inspections.
• Vendor Management: Oversees and drives high-quality outputs from our vendors in support of CRO activities.
• Process Improvement: Develops and maintains aggregate report procedural packages (SOPs, Work Instructions), reports' templates, KPIs, and drives process improvement through automation and other tech initiatives.

Requirements

• Bachelor’s degree required (advanced degree or HCP-focused background preferred) and 5+ years of Pharmacovigilance experience, with a demonstrated focus on Aggregate Safety Reporting.
• Project management experience strongly preferred, PMP preferred.
• Experience with health authority inspections (PV and GCP).
• Medical writing experience with regulatory documentation.
• Strong project management skills.
• Excellent strategic decision-making and analytical skills.
• Strong communication and writing skills.
• Proven experience with technology implementations allowing for streamlined process execution.

Qualifications

• Bachelor’s degree required.
• Advanced degree or HCP-focused background preferred.
• 5+ years of Pharmacovigilance experience, with a focus on Aggregate Safety Reporting.
• Project management experience strongly preferred, PMP preferred.
• Experience with health authority inspections (PV and GCP).
• Medical writing experience with regulatory documentation.
• Strong project management skills.
• Excellent strategic decision-making and analytical skills.
• Strong communication and writing skills.
• Proven experience with technology implementations allowing for streamlined process execution.

Skills

• Preparation and development of Aggregate Reporting (i.e., PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs).
• Expertise in maintaining compliance metrics and implementing CAPA for non-compliance.
• Ability to develop and oversee functional specifications of data requirements for aggregate deliverables.
• Strong collaboration and communication skills.
• Experience with technology implementations for streamlined process execution.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits (e.g. medical, dental, vision, life and disability).
• Paid time off.
• Family support benefits.

Pay

$134,400.00 - $219,200.00 annually

Schedule

Full-time